(28 days)
No
The 510(k) summary describes a mechanical suture anchor and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an implantable suture anchor intended for fixation of soft tissue to bone in various surgical procedures across multiple anatomical sites (shoulder, foot/ankle, knee, hand/wrist, elbow, hip) for repairing injuries or reconstructing ligaments/tendons. This directly indicates a therapeutic purpose.
No
The device description and intended use indicate it is a surgical implant designed for fixation of suture to bone, not for diagnosis.
No
The device description clearly states it is a "sterile two-component suture anchor comprised of an eyelet and a hollow anchor body," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of suture to bone in various anatomical locations during surgical procedures. This is a direct surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a suture anchor, a physical implant used to secure tissue to bone. This is consistent with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
In summary, the Arthrex SwiveLock Suture Anchors are surgical devices used for fixation during procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
. Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, and Quadriceps Tendon Repair. Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only).
- . Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.
. Hip: Capsular repair, acetabular labral repair.
Product codes (comma separated list FDA assigned to the subject device)
MAI, MBI
Device Description
The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, foot/ankle, knee, hand/wrist, elbow, and hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Cyclic pull-out, biocompatibility testing per ISO 10993-1:2018 and pyrogenicity testing was conducted on a representative device and compared to the predicate device to demonstrate that the proposed devices are substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
January 15, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arthrex Inc. Jessica Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K193503
Trade/Device Name: Arthrex SwiveLock Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: December 12, 2019 Received: December 18, 2019
Dear Ms. Singelais:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Laura Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K193503
Device Name Arthrex SwiveLock Suture Anchor
Indications for Use (Describe)
The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ ankle, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
. Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, and Quadriceps Tendon Repair. Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only).
- . Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.
. Hip: Capsular repair, acetabular labral repair.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared | January 15, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Jessica L. Singelais |
| Regulatory Affairs Specialist | |
| 1-239-598-4302, ext. 73091 | |
| Jessica.singelais@arthrex.com | |
| Name of Device | Arthrex SwiveLock Suture Anchor |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MAI, MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| 21 CFR888.3030: Single/multiple component metallic bone fixation appliances | |
| and accessories | |
| Regulatory Class | II |
| Predicate Device | K191226: Arthrex SwiveLock Suture Anchor |
| Reference Device | K173240: Arthrex PushLock Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to add a line extension to the |
| Arthrex SwiveLock Suture Anchors cleared under predicate K191226. | |
| Device Description | The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of |
| an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted | |
| on a driver with the anchor body and eyelet physically separated on the driver shaft. | |
| Arthrex 510(k) cleared suture may also be provided with the device. | |
| Indications for Use | The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (soft tissue) |
| to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following | |
| procedures: | |
| Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps | |
| Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular | |
| Shift or Capsulolabral Reconstruction.Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon | |
| Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal | |
| Ligament Repair/Tendon Repair and Bunionectomy.Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), Medial | |
| Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar | |
| Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band | |
| Tenodesis and Quadriceps Tendon Repair, Secondary fixation for ACL/PCL | |
| reconstruction or repair (4.75-5.5 SwiveLock only).Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial | |
| Collateral Ligament Reconstruction.Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial | |
| Collateral Ligament Reconstruction.Hip: Capsular repair, acetabular labral repair. | |
| Comparison | |
| Summary of | |
| Technological | |
| Characteristics and | |
| Modifications | |
| Proposed | The proposed device is a line extension to the predicate device. The proposed and |
| predicate devices (K191226) have the same basic design, intended use, indications for | |
| use, packaging and sterilization method. In comparison to the predicate device, the | |
| proposed device has an extended shelf life. Proposed modifications consist of a | |
| modified eyelet, knotless suture construct and suture manufacturing process | |
| changes. Any differences between the proposed device and the predicate device are | |
| considered minor and do not raise questions concerning safety or effectiveness. |
4
| Performance Data | Cyclic pull-out, biocompatibility testing per ISO 10993-1:2018 and pyrogenicity testing was conducted on a representative device and compared to the predicate device to demonstrate that the proposed devices are substantially equivalent to the predicate. |
|---|---|
| Conclusion | The proposed Arthrex SwiveLock Suture Anchors are substantially equivalent to the predicate device in which the basic design features and intended uses are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise questions concerning safety or effectiveness. |
| Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the Arthrex SwiveLock is substantially equivalent to the currently marketed predicate device. |